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Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures


N/A
18 Years
N/A
Not Enrolling
Both
Dysphagia

Thank you

Trial Information

Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures


This is a randomized two-arms cross-over trial. In this study there are two groups, the
control group and the triamcinolone treatment group. The cross-over design will apply only
in the control group when patients are not responding to EGD dilations alone (defined as no
sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the
triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.


Inclusion Criteria:



- Patients who present for EGD with dilation for dysphagia symptoms thought secondary
to either radiation-induced stricture or anastomotic stricture based on history

Exclusion Criteria:

- Inability to consent for the procedure

- Coagulopathy [International Normalized Ratio (INR) >1.5, Platelets <75 K]

- Endoscopic finding of a stricture that is not caused by either radiation or
anastomotic narrowing

- Nasopharyngeal strictures

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period

Outcome Description:

The main outcome measured will be number of visits to receive Esophageal Dilation during the 12-month follow-up period. Successful dilation of the stricture for the procedure will be defined as creation of a mucosal tear confirmed by endoscopic visualization after the last dilation is performed.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Jason Klapman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-17316

NCT ID:

NCT01873573

Start Date:

August 2013

Completion Date:

September 2017

Related Keywords:

  • Dysphagia
  • radiation-induced stricture
  • anastomotic stricture
  • esophagogastroduodenoscopy (EGD)
  • dilation
  • steroid injection
  • triamcinolone
  • difficulty swallowing
  • Deglutition Disorders
  • Dilatation, Pathologic
  • Esophageal Stenosis

Name

Location
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Northwestern University Medical Center Chicago, Illinois  60611
UCLA Medical Center Los Angeles, California  90095-7059
California Pacific Medical Center San Francisco, California  94115